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CompletedNCT03641911Updated Jul 16, 2019

Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

An observational study in Adult ICU Patients and Pain, Acute, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
118
Ages
18 Years and older
Sex
All
01

Study summary

In SICU, Siriraj hospital there were no protocols place for the management of pain. All decisions were made according the attending physicians.

There were no information about incidence of inappropriate pain management in SICU due to lack of validated tool for assessment.

To date, Thai-version of BPS and CPOT were validated, the incidence of inappropriate pain management in SICU, Siriraj hospital should be assessed.

02

Conditions studied

  • Adult ICU Patients
  • Pain, Acute

Keywords

  • incidence
  • surgical ICU
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 118 is close to the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult surgical ICU patients

Inclusion criteria

  • Older than 18 years.
  • Expected duration of mechanical ventilation of more than 24 hours.

Exclusion criteria

Exclusion Criteria:

  • Quadriplegia.
  • Receiving neuromuscular blocking medications.
  • Coma or severe brain injury
  • Neurosurgery/ CVT patients/ trauma patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
118 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. overtreatment of pain (Richmond agitation sedation scale)

    Richmond agitation sedation scale -3 to -5 undertreatment NRS 4-10 or CPOT 3-8

    Time frame: day0- 2 after admitted to ICU

  2. inadequate treatment of pain (Numeral rating scale)

    Numeral rating scale 4-10 in communicable patient or critical care pain observation tool 3-8 in non-communicable patients

    Time frame: day 0-2 after admitted to ICU

Secondary outcomes

  1. Mortality rate

    Time frame: 30 days after admitted to ICU

  2. ICU length of stay

    Time frame: 30 days after admitted to ICU

  3. Duration of mechanical ventilation

    Time frame: 30 days after admitted to ICU

  4. Incidence of acquired complication

    * Ventilator associated pneumonia * GI hemorrhage * Venous thromboembolism * Central venous catheter colonization

    Time frame: 30 days after admitted to ICU

07

Study locations

1 site
  • Karuna Wongtangman
    Bangkok Noi, Bangkok 10170, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03641911
Lead sponsor
Mahidol University
Responsible party
Karuna Wongtangman (Instructor, Mahidol University) — Principal investigator
First posted
Aug 22, 2018
Start date
Nov 15, 2017
Primary completion
Jan 31, 2019
Completion
Feb 15, 2019
Last update
Jul 16, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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